Las Palmas De Gran Canaria

Researchers are evaluating the safety and effectiveness of personalized, dynamic titanium prostheses designed to reconstruct the chest wall after tumor removal, severe trauma, or other chest defects. Traditional reconstruction methods often use rigid materials that can cause discomfort and breathing difficulties. This study aims to test 3D-printed titanium implants that mimic natural rib movement, potentially improving breathing function and patient comfort. The study is a multicenter registry combining past and new cases from major Spanish hospitals, running prospectively from January 2024 to January 2026 with follow-up through 2027. Participants receive a custom prosthesis created using a preoperative CT scan and manufactured from titanium alloy using electron beam melting. Surgery involves removing the affected chest wall segment and implanting the custom prosthesis anchored to the ribs and sternum. Follow-up evaluations occur at hospital discharge, 1 month, 6 months, and 12 months after surgery. The prosthesis is designed to restore chest wall structure and allow dynamic flexibility similar to natural rib movement. Throughout the study, participants undergo assessments including lung function tests, pain scales, CT imaging, and quality of life questionnaires. Data on surgical details, prosthesis characteristics, complications, and functional outcomes are securely collected and analyzed. The primary outcomes focus on changes in lung function measured by various spirometric parameters from baseline to one year after surgery. The total participation time includes surgery and a 12-month follow-up period, with data handling compliant with privacy regulations.

Preterm birth before 37 weeks' gestation is common and linked to many health challenges, especially when it occurs before 29 weeks. At this early stage, infants often face breathing difficulties due to immature lungs, sometimes requiring resuscitation. This study aims to compare two oxygen concentrations, 30% and 60%, used during resuscitation of very preterm infants to determine which leads to better survival and neurodevelopmental outcomes by about two years of age. The study uses a cluster randomized crossover design, where hospitals alternate between using 30% and 60% oxygen to resuscitate infants born between 23 and 28 weeks gestation. Infants receive the assigned oxygen concentration for the first 5 minutes after birth, with adjustments made based on oxygen saturation levels to maintain safe ranges. The intervention lasts 10 minutes, including initial resuscitation and oxygen titration to stabilize the infant. Participants will be closely monitored during their hospital stay and followed up at 24 months corrected age to assess survival and major neurodevelopmental outcomes. Data collected will include oxygen saturation, heart rate during resuscitation, and longer-term health measures. The study's results aim to guide safer oxygen use in resuscitating extremely preterm infants worldwide.

Researchers are evaluating new treatment options for adults with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This study compares the safety and effectiveness of adding calderasib and cetuximab, both targeted therapies, to a standard chemotherapy regimen called mFOLFOX6. The goal is to see if this combination can help patients live longer without their cancer growing or spreading compared to current treatments that may include mFOLFOX6 with or without bevacizumab. The study has two parts. It involves treatment with calderasib taken as an oral tablet, cetuximab given according to standard procedures, and mFOLFOX6 chemotherapy combining oxaliplatin, leucovorin/levofolinate calcium, and 5-fluorouracil. Some participants may receive bevacizumab or a bevacizumab biosimilar as part of the comparison. The treatments are given following approved dosing schedules. This design allows researchers to assess the safety and tolerability of these drug combinations in treating this type of colorectal cancer with the KRAS G12C mutation. Participants will be monitored for side effects, treatment tolerability, and cancer progression over a period that may last up to about 44 months. Researchers will track outcomes such as how many participants experience dose-limiting toxicities or adverse events, how many stop treatment due to side effects, and progression-free survival time. Assessments include health evaluations, laboratory tests, and imaging to observe cancer status. This long-term follow-up aims to understand both safety and effectiveness of the treatment combinations.

Researchers are evaluating new treatments for people with high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that has not spread to the muscle but has a high chance of worsening or returning. This cancer type may include carcinoma in situ (CIS), which is a flat, surface-level bladder cancer. The study aims to learn whether adding intismeran autogene (V940), a treatment designed to boost the immune system's attack on cancer, to the standard Bacillus Calmette-Guerin (BCG) immunotherapy can help people live longer without the cancer growing, spreading, or coming back. Participants will receive either the combination of V940 with BCG or BCG alone. BCG is given as a bladder instillation, while V940 is given as an intramuscular injection. The study is phase 2, open-label, and randomized. As of a 2026 amendment, outcome measures for a monotherapy arm of V940 are no longer primary or secondary. Treatment is focused on Cohort A, which includes people with high-risk non-muscle invasive bladder cancer who are BCG-naïve or meet specific recurrence criteria. During the study, participants will be monitored for event-free survival for up to approximately 5 years. Researchers will assess how long participants live without the cancer worsening or returning. The study includes regular evaluations, imaging, and safety monitoring. The total duration of participation depends on individual outcomes and follow-up but includes long-term observation to assess treatment effects and safety.

Researchers are investigating new treatment options for people with locally advanced or metastatic urothelial cancer, a type of bladder cancer. This trial focuses on comparing a medicine called sacituzumab tirumotecan (sac-TMT) with certain non-platinum chemotherapy drugs. The goal is to find out if sac-TMT can help people live longer after their cancer has worsened following previous treatments, including immunotherapy, chemotherapy, and targeted therapy. This is a Phase 3 randomized, open-label study. Participants receive either sacituzumab tirumotecan or one of the chemotherapy drugs vinflunine, docetaxel, or paclitaxel through intravenous (IV) infusions. Rescue medications may also be given to manage side effects, based on the investigator’s judgment and approved treatment guidelines. The study compares these treatments to evaluate their effects on the cancer and survival. During the trial, participants will be closely monitored with regular assessments to measure overall survival, the main outcome of the study, over about 40 months. Researchers will check participants' health, cancer progression, and organ function, and collect tumor tissue samples when possible. Safety and side effects will be tracked throughout the study to understand the treatments’ impacts and support participant well-being.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating ELVN-001, a new drug, in adults with chronic myeloid leukemia (CML), including those with or without a specific T315I mutation. This early phase 1a/1b study aims to find the best dose of ELVN-001 for future studies by assessing its safety, tolerability, and how the body processes the drug. The study also looks at changes in a key leukemia marker called BCR-ABL1 to gather initial evidence of the drug's effect on CML. Participants will receive ELVN-001 orally once or twice daily. The trial includes a dose escalation period to identify recommended doses for further research. This first-in-human study will monitor patients closely to understand the safety profile and pharmacokinetics of ELVN-001. The drug is being tested in patients who have relapsed, are resistant, or cannot tolerate other tyrosine kinase inhibitors (TKIs). Throughout the study, participants will be monitored for adverse events, dose-limiting toxicities, and any significant lab or heart test abnormalities up to 28 days in phase 1a and for up to 3 years in phase 1b. Researchers will assess safety, tolerability, and leukemia markers regularly. The total duration of monitoring allows for a thorough evaluation of ELVN-001's effects and safety in adults with chronic phase CML.

The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time. The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.

Researchers are studying the real-world effectiveness of pegcetacoplan in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This long-term, multicenter observational study aims to fill knowledge gaps about how pegcetacoplan works in routine medical practice. It also seeks to provide important information on red blood cell transfusions and healthcare resource use before and after starting pegcetacoplan treatment. Patients who have started pegcetacoplan treatment within the last 12 months or are prescribed it at enrollment will be followed for approximately 36 months. The study will collect both retrospective data from up to 12 months before treatment start and prospective data during treatment, with a total data collection period of up to about 48 months. After stopping pegcetacoplan, patients will remain in the study for 8 weeks to monitor for any adverse events. Participants will attend their usual medical visits, and data from these visits will be collected, including effectiveness measures, safety reports, patient- and clinician-reported outcomes, and healthcare use. The primary outcome includes changes in hemoglobin levels over 6 months from the start of pegcetacoplan treatment. The study plans to enroll about 200 patients across multiple countries, and data collection includes both retrospective and prospective periods, capturing comprehensive information on pegcetacoplan use in real-world settings.